Blog2021-11-17T16:12:08-03:00
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ANVISA – Sistema Solicita

ANVISA - Sistema Solicita Para submissão de documentos para peticionamento de processos na Agência Nacional de Vigilância Sanitária - ANVISA, existem atualmente dois sistemas: PETICIONAMENTO ELETRÔNICO E SISTEMA SOLICITA. O Sistema Solicita foi desenvolvido internamente pela ANVISA para tornar as demandas de usuários aos serviços [...]

ANVISA – RDC No. 687 GMP

ANVISA - RDC No. 687 provides the criteria for granting or renewing the Certification of Good Manufacturing Practices for Medical Devices Published on May 13th: RDC No. 687 provides the criteria for granting or renewing the Certification of Good Manufacturing Practices for Medical Devices. The [...]

ANVISA – SOLICITA SYSTEM

ANVISA - Solicita System For submission of documents for petitioning processes at the National Health Surveillance Agency – ANVISA, there are currently two systems: ELECTRONIC PETITION and SOLICITA SYSTEM. The Solicita System was developed internally by ANVISA to make the demands of users to the [...]

UDI for Brazil – ANVISA

UDI for Brazil - ANVISA Published on December 29th, 2021, and effective as of January 10, 2022, ANVISA informed that it will require the UDI (Unique Device Identifier) in the labeling of registered products and marketed in Brazil. The UDI is composed of the UDI-DI [...]

Anvisa Quality System Management

ANVISA Quality System Management Implementation and Maintenance   If you export medical devices to Brazil, getting ANVISA registration is the first step to making them viable in the market.  ANVISA requires you to ensure that all your manufacturing locations meet Brazilian Good Manufacturing Practices (GMP) requirements, the local equivalent of the  [...]

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